Trial Outcomes & Findings for Feasibility of a New Ambulatory Multi-vital Signs Monitor (NCT NCT05562011)

Results Overview

Number of participants who had the presence of (data existing for at least 70% of 5-minute time periods) for all of the vital signs of interest together--heart rate (HR), blood pressure (BP), respiratory rate (RR), arterial oxygen saturation (SaO2) after placement of the device on the subject's wrist and hand.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

Baseline

Results posted on

2023-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	Caretaker Device participants will undergo active CarTaker monitoring for 24-48 hours
Overall Study STARTED	61
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Caretaker Device participants will undergo active CarTaker monitoring for 24-48 hours
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	1
Overall Study Could not co-enroll with other research study--device could not be placed postop	1
Overall Study Device not placed postop due to patient being discharged home after surgery (not staying overnight)	4
Overall Study Device malfunction	13

Baseline Characteristics

Feasibility of a New Ambulatory Multi-vital Signs Monitor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Caretaker Device Placement n=61 Participants Caretaker Device placement: placement of the Caretaker device at preanesthesia visit and again postoperatively
Age, Continuous	62.1 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Number of participants who had the presence of (data existing for at least 70% of 5-minute time periods) for all of the vital signs of interest together--heart rate (HR), blood pressure (BP), respiratory rate (RR), arterial oxygen saturation (SaO2) after placement of the device on the subject's wrist and hand.

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Preoperative Caretaker Monitor Placement Success	39 Participants

PRIMARY outcome

Timeframe: Pre-Op Hour 24

Participants' description of ease of use (interfered with Activities of Daily Living (ADLs) or sleep) in Yes/No format. Data will be collected to demonstrate percent of patients who answered "Yes" to Sleep or ADL interference. Free text will also be recorded for qualitative purposes. Shows Caretaker Feasibility.

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Ease of Use Determined by Number of Participants With Sleep or Activities of Daily Living (ADLs) Interference	16 Participants

PRIMARY outcome

Timeframe: Post-Op Hour 24

Population: Data not collected

Using postoperative nurse verbal feedback on usability of the Caretaker monitor on subjects scheduled for surgery during the perioperative period. Percent of nurses who answer yes to the question: Did you have any difficulty using the Caretaker monitor?

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-Op Hour 24

Population: data not collected

Number of participants with no missing values expressed

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Intraoperative; from the time the Operating Room monitors are placed on the patient until they come off at the end of the case, an average of 2 hours

Number of participants with no missing values expressed

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Caretaker Data Capture Rate	39 Participants

PRIMARY outcome

Timeframe: Post-Op Hour 24

Population: data not collected

Number of participants with no missing values expressed

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline through Pre-Op Hour 24

Percent of monitors returned to our research technicians

Outcome measures

Outcome measures
Measure	Caretaker Device n=61 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Monitor Return Rate	61 Participants

SECONDARY outcome

Timeframe: Pre-Op hour 24, Post-Op Hour 24

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Heart Rate Pre-Op Hour 24	94 beats per minute Standard Deviation 19
Heart Rate Post-Op Hour 24	87 beats per minute Standard Deviation 15

SECONDARY outcome

Timeframe: Pre-Op Hour 24, Post-Op Hour 24

Percentage of time heart rate is \<60 bpm or \>90 bpm

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Heart Rate--percent of Time Parameters Pre-Op Hour 24	55 percentage of time Standard Deviation 3
Heart Rate--percent of Time Parameters Post-Op Hour 24	40 percentage of time Standard Deviation 4

SECONDARY outcome

Timeframe: Pre-Op hour 24, Post-Op Hour 24

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Respiratory Rate Pre-Op Hour 24	17 respirations per minute Standard Deviation 4
Respiratory Rate Post-Op Hour 24	17 respirations per minute Standard Deviation 4

SECONDARY outcome

Timeframe: Pre-Op hour 24, Post-Op Hour 24

Percent of time respirations are \<8 rpm or \>20 rpm

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Respiratory Rate--Percent of Time Parameters Pre-Op Hour 24	21.6 percentage of time Standard Deviation 3.8
Respiratory Rate--Percent of Time Parameters Post-Op Hour 24	15.9 percentage of time Standard Deviation 3.5

SECONDARY outcome

Timeframe: Post-Op Hour 24

Population: data not collected

oxygen saturation level as detected by the pulse oximeter

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-Op Hour 24, Post-Op Hour 24

Population: data not collected for either time point

Percentage of time SaO2 is between 95-100%

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-Op Hour 24, Post-Op Hour 24

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Non-Invasive Systolic Blood Pressure (SBP) Pre-Op Hour 24	119 units of millimeters of mercury (mmHg) Standard Deviation 22
Non-Invasive Systolic Blood Pressure (SBP) Post-Op Hour 24	134 units of millimeters of mercury (mmHg) Standard Deviation 24

SECONDARY outcome

Timeframe: Pre-Op Hour 24, Post-Op Hour 24

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Non-Invasive Mean Arterial Blood Pressure (MBP) Pre-Op Hour 24	82 mm of Hg Standard Deviation 18
Non-Invasive Mean Arterial Blood Pressure (MBP) Post-Op Hour 24	97 mm of Hg Standard Deviation 21

SECONDARY outcome

Timeframe: Pre-Op Hour 24, Post-Op Hour 24

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Non-Invasive Diastolic Blood Pressure (DBP) Post-Op Hour 24	68 mm of Hg Standard Deviation 16
Non-Invasive Diastolic Blood Pressure (DBP) Pre-Op Hour 24	58 mm of Hg Standard Deviation 16

SECONDARY outcome

Timeframe: Pre-Op Hour 24, Post-Op Hour 24

Percent time MBP is \<60 mmHg and/or \>90 mmHg

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Non-Invasive Blood Pressure--MBP Percent of Time Parameters Pre-Op Hour 24	37 percentage of time Standard Deviation 4
Non-Invasive Blood Pressure--MBP Percent of Time Parameters Post-Op Hour 24	67 percentage of time Standard Deviation 1

SECONDARY outcome

Timeframe: Day 30

Percent declared dead

Outcome measures

Outcome measures
Measure	Caretaker Device n=61 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Mortality Rate	0 Participants

SECONDARY outcome

Timeframe: Up to Postoperative Day 30

Number of days from hospital admission to discharge

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Average Length of Hospital Stay	3.5 number of days Standard Deviation 4.3

SECONDARY outcome

Timeframe: Up to Postoperative Day 30

Percent of study participants transferred to an ICU during their hospital stay

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
ICU Transfer Rate	10 Participants

SECONDARY outcome

Timeframe: During hospitalization up to Postoperative Day 30

Number of calls made to the hospital's "Rapid Response Team" (RRT) during subjects' hospital stay. The RRT is called by nurses if the patient is experiencing stroke-like symptoms, chest pain refractory to medical treatment, or vital signs (HR, RR, BP, SaO2) meeting a pre-defined out of range value.

Outcome measures

Outcome measures
Measure	Caretaker Device n=39 Participants participants will undergo active CareTaker monitoring for 24-48 hours
Number of Rapid Response Team Calls	2 calls

Adverse Events

Caretaker Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Timothy Harwood, M.D.

Wake Forest University School of Medicine

Phone: 336.716.8830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place